ApprovalTrail

Medical device licence · 15459 · Class 3

COMPUTERISED CARDIOLAB SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed December 22, 1999; ended October 31, 2000. It is in Health Canada’s archive of licences no longer in force.
Licence number
15459
Licence holder
Prucka Engineering IncSugar Land, TX, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Group
First licensed
December 22, 1999
Ended
October 31, 2000
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • CARDIOLAB CATH SYSTEM
  • CARDIOLAB HIGH RES. DUAL MONITOR COMPUTERIZED ELECTROPHYSIOLOGY LAB SYSTEM

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.